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IRCT20230110057104N1 IRCT 2023-02-17 Islamic Azad University Evaluation of Effect of Hydroalcoholic Pomegranate Extract on Plaque Formation Evaluation of Clinical Effect of Hydroalcoholic Extract of Whole Pomegranate Fruit on Dental Plaque Formation in 8-10-Year-Old Children 2023-02-05 anticipated 14 Complete https://irct.ir/trial/68125 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: This cross-over study includes two treatments A (framed mouthwash) and B (unframed mouthwash) and people are placed in AB and BA groups in a simple random manner using a table of random numbers with the help of Rand option of Excel software, Blinding description: The two mouthwashes are completely identical in terms of the bottle, color, and by adding flavoring, and the mouthwashes are given to the participant in framed and unframed form with the indication of how to use them. Plaque evaluation and data collection is done by a pediatric specialist who is not aware of the studied groups. N/A The effect of Mouthwash on the Formation of Microbial Plaque. Intervention 1: Intervention group:10 mL of the Hydroalcoholic Pomegranate mouthwash rinse twice a day and then spit it out for 2 days. Intervention 2: Control group: 10 mL of the chlorhexidine mouthwash rinse twice a day and then spit it out for 2 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participants do not wish to share their information.
public Sara Tavassoli Hojati
No 10, Karimi Ave, Yarmohamadi Ave, darus,Tehran
Tehran Iran (Islamic Republic of) 1955819973 +98 21 2255 9108 tavasolisara@yahoo.com Islamic Azad University scientific Sara Tavassoli Hojati
No 10, Karimi Ave, Yarmohamadi Ave, darus,Tehran
Tehran Iran (Islamic Republic of) 1955819973 +98 21 2255 9108 tavasolisara@yahoo.com Islamic Azad University Iran (Islamic Republic of) Systemic Health No Antibiotic Intake within the Past 3 Weeks Prior to the Study Onset Absence of Oral Habits No Use of Orthodontic or Prosthetic Appliances No Xerostomia No Periodontal disease, and Absence of Active Caries in the Buccal and Lingual Surfaces of Maxillary Right First Molar, Mandibular Left First Molar, Maxillary Left Lateral Incisor, Mandibular Right lateral Incisor, Maxillary Right Central Incisor, and Mandibular Left Central Incisor. Age 8-10 years 8 years 10 years Male Lack of cooperation to use mouthwash Taking another mouthwash now Allergy to mouthwash ingredients Not paying attention to the instructions during the study, including not using gum and not brushing teeth in 48 hours K02 Dental caries Prevention Prevention Intervention group:10 mL of the Hydroalcoholic Pomegranate mouthwash rinse twice a day and then spit it out for 2 days. Control group: 10 mL of the chlorhexidine mouthwash rinse twice a day and then spit it out for 2 days. The Amount of Dental Plaque Formation. Timepoint: 3,5,14. Method of measurement: Dental Plaque Disclosing Tablets. Islamic Azad University Approved 2023-02-04 Ethics Committee of Faculty of Dentistry, Tehran Islamic Azad University of Medical Sciences No 11, Yas Ave, Sohanak,Tehran Tehran Tehran Iran (Islamic Republic of)